NSAIDs linked to bleeding, thromboembolism risk in AF
The use of nonsteroidal anti-inflammatory drugs is associated with an increased risk for serious bleeding and thromboembolism among patients with atrial fibrillation, according to recent findings.
In an observational cohort study, researchers reviewed data on 150,900 patients collected from a nationwide registry in Denmark. All patients were aged at least 30 years (median age, 75 years) and had been hospitalized with a first-time diagnosis of AF between 1997 and 2011. The cohort was 47% female.
Use of the following treatment regimens was recorded: single-antiplatelet therapy with aspirin or clopidogrel; monotherapy with an oral anticoagulant, or dual therapy with an oral anticoagulant and a single antiplatelet. NSAID use also was recorded. The primary outcome was serious bleeding, defined as hospitalization or death due to intracranial, gastrointestinal or respiratory/urinary tract bleeding, or anemia resulting from bleeding during a median follow-up of 6.2 years. Secondary endpoints included death or hospitalization due to thromboembolism, along with all-cause mortality.
Patients received an antiplatelet or oral anticoagulant at baseline in 69.8% of cases, whereas 5% received a concomitant NSAID. During follow-up, 35.6% of the patients were prescribed an NSAID.
Serious bleeding events occurred in 11.4% of patients, and 13% experienced thromboembolism. Death occurred in 48.8% of the population, and 12.4% of observed bleeding events were fatal.
At 3 months, the absolute risk for serious bleeding within 14 days of taking an NSAID was 3.5 events per 1,000 patients vs. 1.5 events per 1,000 patients among those who did not take an NSAID (risk difference, 1.9 events per 1,000 patients). Among patients placed on a regimen of oral anticoagulants, the difference in absolute risk compared with those on NSAIDs was 2.5 events per 1,000 patients. Risk for serious bleeding (HR=2.27; 95% CI, 2.15-2.4) and thromboembolism (HR=1.36; 95% CI, 1.27-1.45) was associated with NSAID use compared with nonuse across all antithrombotic regimens and NSAID types.
Risk for all-cause mortality was significantly increased among concomitant NSAID users. Among patients hospitalized for a nonfatal bleeding incident, prognosis was poorer among those with NSAID exposure at the time of the event (HR=1.22; 95% CI, 1.12-1.33). An NSAID dosage exceeding the minimum recommended dose further increased bleeding risk, the researchers wrote, even with short-term NSAID use.
“These results suggest that physicians should exercise caution when prescribing any NSAIDs in patients with AF receiving antithrombotic therapy, and should choose safer alternative analgesic agents when possible,” the researchers concluded.
Disclosure: See the full study for a list of relevant financial disclosures.